珠海丽拓五联检仪器及试剂临床应用评价

The evaluation of clinical application of Zhuhai Lituo multi instrument test and reagents

目的评价珠海丽拓白带五联检仪器和试剂在临床应用上的价值。方法 908例妇科门诊患者阴道分泌物标本同时用珠海丽拓五联检仪器检测和显微镜镜检,用kappa检验比较两种方法。结果珠海丽拓五联检结果与镜检结果相比较:过氧化氢诊断符合率为89.4%,假阴性率8.87%,κ=0.786,U=19.2,P<0.05一致性良好;白细胞酯酶诊断符合率为47.1%;细菌性阴道病(BV)诊断符合率为96.9%,假阴性率11.8%,κ=0.793,U=10.3,P<0.05一致性良好;真菌、滴虫诊断符合率为78.9%,假阴性率52.9%,κ=0.448,U=6.31,P<0.05一致性中等。结论珠海丽拓白带五联检仪器真菌、滴虫结果假阴性率高,不能取代显微镜镜检;而过氧化氢、白细胞酯酶、唾液酸苷酶与镜检结果一致性良好,可以满足基层医院临床使用要求。

Objective To evaluate the clinical value of Zhuhai Lituo multi instrument test and reagents for leucorrhoea examination.Methods The vaginal secretions from 908 gynecological outpatients were tested with the Zhuhai Lituo multi instrument test and microscopic examination.The result of two methods was analyzed by kappa test.Results Compared with the microscopic examination,the result of Zhuhai Lituo multi instrument test was as following：diagnosis coincidence rate of hydrogen peroxide was 89.4%.The false negative rate was 8.87%,κ=0.786,U=19.2,P〈0.05,which had good consistency;The diagnosis coincidence rate of leukocyte esterase was 47.1%;The diagnosis coincidence rate of bacterial vaginosis（BV） was 96.9%.The false negative rate was 11.8%,κ=0.793,U=10.3,P〈0.05,which had good consistency;The diagnosis coincidence rate of fungus and trichomonas was 78.9%.The false negative rate was 52.9%,κ=0.448,U=6.31,P〈0.05,which had medium consistency.Conclusion Because of the high false negative rate of fungus and trichomonas test,Zhuhai Lituo multi instrument test cannot replace microscopical examination;but there is no significant difference with microscopic examination in detecting hydrogen peroxide,leukocyte esterase and neuraminidase,therefore it can satisfy the clinical requirements of basic-level hospital.